Transcript

This product is available as the above names/strengths but will be referred to as
CRESTOR throughout the leaflet.
CRESTOR is available in four strengths: 5 mg, 10 mg, 20 mg and 40 mg.
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine because
it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It
may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1) What CRESTOR is and what it is used for
2) What you need to know before you take CRESTOR
3) How to take CRESTOR
4) Possible side effects
5) How to store CRESTOR
6) Contents of the pack and other information

1. WHAT CRESTOR IS AND WHAT IT IS USED FOR
CRESTOR belongs to a group of medicines called statins.
You have been prescribed CRESTOR because:
• You have a high cholesterol level. This means you are at risk from a heart attack or
stroke.
You have been advised to take a statin, because changing your diet and taking more
exercise were not enough to correct your cholesterol levels. You should continue with your
cholesterol-lowering diet and exercise while you are taking CRESTOR.
Or
• You have other factors that increase your risk of having a heart attack, stroke or related
health problems.
Heart attack, stroke and other problems can be caused by a disease called
atherosclerosis. Atherosclerosis is due to build up of fatty deposits in your arteries.
Why is it important to keep taking CRESTOR?
CRESTOR is used to correct the levels of fatty substances in the blood called lipids, the
most common of which is cholesterol.
There are different types of cholesterol found in the blood – ‘bad’ cholesterol (LDL-C) and
‘good’ cholesterol (HDL-C).
• CRESTOR can reduce the ‘bad’ cholesterol and increase the ‘good’ cholesterol.
• It works by helping to block your body’s production of ‘bad’ cholesterol. It also improves
your body’s ability to remove it from your blood.
For most people, high cholesterol does not affect the way they feel because it does not
produce any symptoms. However, if it is left untreated, fatty deposits can build up in the
walls of your blood vessels causing them to narrow.
Sometimes, these narrowed blood vessels can get blocked which can cut off the blood
supply to the heart or brain leading to a heart attack or a stroke. By lowering your
cholesterol levels, you can reduce your risk of having a heart attack, a stroke or related
health problems.
You need to keep taking CRESTOR, even if it has got your cholesterol to the right level,
because it prevents your cholesterol levels from creeping up again and causing build
up of fatty deposits. However, you should stop if your doctor tells you to do so, or you have
become pregnant.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CRESTOR
Do not take CRESTOR:
• If you have ever had an allergic reaction to CRESTOR, or to any of its ingredients.
• If you are pregnant or breast-feeding. If you become pregnant while taking CRESTOR
stop taking it immediately and tell your doctor. Women should avoid becoming
pregnant while taking CRESTOR by using suitable contraception.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle aches or pains.
• If you take a drug called ciclosporin (used, for example, after organ transplants)
If any of the above applies to you (or you are in doubt), please go back and see your
doctor.
In addition, do not take CRESTOR 40 mg (the highest dose):
• If you have moderate kidney problems (if in doubt, please ask your doctor).
• If your thyroid gland is not working properly.
• If you have had any repeated or unexplained muscle aches or pains, a personal
or family history of muscle problems, or a previous history of muscle problems when
taking other cholesterol-lowering medicines.
• If you regularly drink large amounts of alcohol.
• If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and
Indian).
• If you take other medicines called fibrates to lower your cholesterol.
If any of the above applies to you (or you are in doubt), please go back and see your
doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking CRESTOR.
• If you have problems with your kidneys.
• If you have problems with your liver.
• If you have had repeated or unexplained muscle aches or pains, a personal or
family history of muscle problems, or a previous history of muscle problems when
taking other cholesterol-lowering medicines. Tell your doctor immediately if you have
unexplained muscle aches or pains especially if you feel unwell or have a fever. Also
tell your doctor or pharmacist if you have a muscle weakness that is constant.
• If you regularly drink large amounts of alcohol.
• If your thyroid gland is not working properly.
• If you take other medicines called fibrates to lower your cholesterol. Please read
this leaflet carefully, even if you have taken other medicines for high cholesterol before.
• If you take medicines used to treat the HIV infection e.g. ritonavir with lopinavir
and/or atazanavir, please see Other medicines and CRESTOR.
Children and adolescents
• If the patient is under 10 years old: CRESTOR should not be given to children
younger than 10 years.
• If the patient is below 18 years of age: The CRESTOR 40 mg tablet is not suitable
for use in children and adolescents below 18 years of age.
• If you are over 70 (as your doctor needs to choose the right start dose of CRESTOR
to suit you).
• If you have severe respiratory failure.
• If you are of Asian origin – that is Japanese, Chinese, Filipino, Vietnamese, Korean
and Indian. Your doctor needs to choose the right start dose of CRESTOR to suit you.
If any of the above applies to you (or if you are not sure):
• Do not take CRESTOR 40 mg (the highest dose) and check with your doctor or
pharmacist before you actually start taking any dose of CRESTOR.
In a small number of people, statins can affect the liver. This is identified by a simple test
which looks for increased levels of liver enzymes in the blood. For this reason, your doctor
will usually carry out this blood test (liver function test) before and during treatment with
CRESTOR.
While you are on this medicine your doctor will monitor you closely if you have diabetes or
are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you
have high levels of sugars and fats in your blood, are overweight and have high blood
pressure.
Other medicines and CRESTOR
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Tell your doctor if you are taking any of the following: ciclosporin (used for example, after
organ transplants), warfarin (or any other drug used for thinning the blood), fibrates (such
as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as
ezetimibe), indigestion remedies (used to neutralise acid in your stomach), erythromycin
(an antibiotic), an oral contraceptive (the pill), hormone replacement therapy or ritonavir
with lopinavir and/or atazanavir (used to treat the HIV infection – please see Warnings and
precautions). The effects of these medicines could be changed by CRESTOR or they could
change the effects of CRESTOR.
Pregnancy and breast-feeding
Do not take CRESTOR if you are pregnant or breast-feeding. If you become pregnant
while taking CRESTOR stop taking it immediately and tell your doctor. Women should
avoid becoming pregnant while taking CRESTOR by using suitable contraception.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Most people can drive a car and operate machinery while using CRESTOR – it will not
affect their ability. However, some people feel dizzy during treatment with CRESTOR. If
you feel dizzy, consult your doctor before attempting to drive or use machines.
CRESTOR contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars (lactose
or milk sugar), contact your doctor before taking CRESTOR.
For a full list of ingredients please see Contents of the pack and other information.

3. HOW TO TAKE CRESTOR
Always take CRESTOR as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
The following is an English translation for the days of the week, which may appear in
French on the calendar blister strips.
MON
Lun

TUES
Mar

WED
Mer

THURS
Jeu

FRI
Ven

SAT
Sam

SUN
Dim

Usual doses in adults
If you are taking CRESTOR for high cholesterol:
Starting dose
Your treatment with CRESTOR must start with the 5 mg or the 10 mg dose, even if you
have taken a higher dose of a different statin before. The choice of your start dose will
depend upon:
• Your cholesterol level.
• The level of risk you have of experiencing a heart attack or stroke.
• Whether you have a factor that may make you more sensitive to possible side effects.
Please check with your doctor or pharmacist which start dose of CRESTOR will best suit
you.

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Your doctor may decide to give you the lowest dose (5 mg) if:
• You are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
• You are over 70 years of age.
• You have moderate kidney problems.
• You are at risk of muscle aches and pains (myopathy).
Increasing the dose and maximum daily dose
Your doctor may decide to increase your dose. This is so that you are taking the amount of
CRESTOR that is right for you.
If you started with a 5 mg dose, your doctor may decide to double this to 10 mg, then
20 mg and then 40 mg if necessary.
If you started on 10 mg, your doctor may decide to double this to 20 mg and then 40 mg if
necessary. There will be a gap of four weeks between every dose adjustment.
The maximum daily dose of CRESTOR is 40 mg. It is only for patients with high cholesterol
levels and a high risk of heart attacks or stroke whose cholesterol levels are not lowered
enough with 20 mg.
If you are taking CRESTOR to reduce your risk of having a heart attack, stroke or
related health problems:
The recommended dose is 20 mg daily. However, your doctor may decide to use a lower
dose if you have any of the factors mentioned above.
Use in children and adolescents aged 10-17 years
The usual start dose is 5 mg. Your doctor may increase your dose to find the right amount
of CRESTOR for you. The maximum daily dose of CRESTOR is 20 mg. Take your dose
once a day. CRESTOR 40 mg tablet should not be used by children.
Taking your tablets
Swallow each tablet whole with a drink of water.
Take CRESTOR once daily. You can take it at any time of the day with or without food.
Try to take your tablet at the same time every day to help you to remember it.
Regular cholesterol checks
It is important to go back to your doctor for regular cholesterol checks, to make sure your
cholesterol has reached and is staying at the correct level.
Your doctor may decide to increase your dose so that you are taking the amount of
CRESTOR that is right for you.
If you take more CRESTOR than you should
Contact your doctor or nearest hospital for advice.
If you go into hospital or receive treatment for another condition, tell the medical staff that
you’re taking CRESTOR.
If you forget to take CRESTOR
Don’t worry, just take your next scheduled dose at the correct time. Do not take a double
dose to make up for a forgotten dose.
If you stop taking CRESTOR
Talk to your doctor if you want to stop taking CRESTOR. Your cholesterol levels might
increase again if you stop taking CRESTOR.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets
them.
It is important that you are aware of what these side effects may be. They are usually mild
and disappear after a short time.
Stop taking CRESTOR and seek medical help immediately if you have any of the
following allergic reactions:
• Difficulty in breathing, with or without swelling of the face, lips, tongue and/or throat
• Swelling of the face, lips, tongue and/or throat, which may cause difficulty in
swallowing
• Severe itching of the skin (with raised lumps).
Also, stop taking CRESTOR and talk to your doctor immediately if you have any
unusual aches or pains in your muscles which go on for longer than you might expect.
Muscle symptoms are more common in children and adolescents than in adults. As with
other statins, a very small number of people have experienced unpleasant muscle effects
and rarely these have gone on to become a potentially life threatening muscle damage
known as rhabdomyolysis.
Common possible side effects (these may affect between 1 in 10 and 1 in 100
patients):
• Headache
• Stomach pain
• Constipation
• Feeling sick
• Muscle pain
• Feeling weak
• Dizziness
• An increase in the amount of protein in the urine - this usually returns to normal on its
own without having to stop taking your CRESTOR tablets (only CRESTOR 40 mg)
• Diabetes. This is more likely if you have high levels of sugars and fats in your blood,
are overweight and have high blood pressure. Your doctor will monitor you while you
are taking this medicine.

Uncommon possible side effects (these may affect between 1 in 100 and 1 in 1,000
patients):
• Rash, itching or other skin reactions
• An increase in the amount of protein in the urine - this usually returns to normal on its
own without having to stop taking your CRESTOR tablets (only CRESTOR 5 mg,
10 mg and 20 mg).
Rare possible side effects (these may affect between 1 in 1,000 and 1 in 10,000
patients):
• Severe allergic reaction – signs include swelling of the face, lips, tongue and/or throat,
difficulty in swallowing and breathing, a severe itching of the skin (with raised lumps).
If you think you are having an allergic reaction, then stop taking CRESTOR and
seek medical help immediately
• Muscle damage in adults – as a precaution, stop taking CRESTOR and talk to your
doctor immediately if you have any unusual aches or pains in your muscles which
go on for longer than expected
• A severe stomach pain (inflamed pancreas)
• Increase in liver enzymes in the blood.
Very rare possible side effects (these may affect less than 1 in 10,000 patients):
• Jaundice (yellowing of the skin and eyes)
• Hepatitis (an inflamed liver)
• Traces of blood in your urine
• Damage to the nerves of your legs and arms (such as numbness)
• Joint pain
• Memory loss
• Breast enlargement in men (gynaecomastia)
Side effects of unknown frequency may include:
• Diarrhoea (loose stools)
• Stevens-Johnson syndrome (serious blistering condition of the skin, mouth, eyes and
genitals)
• Cough
• Shortness of breath
• Oedema (swelling)
• Sleep disturbances, including insomnia and nightmares
• Sexual difficulties
• Depression
• Breathing problems, including persistent cough and/or shortness of breath or fever
• Tendon injury
• Muscle weakness that is constant
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more information on the safety of this
medicine.

5. HOW TO STORE CRESTOR
• Keep out of the sight and reach of children.
• Do not store your tablets above 30˚C
• Store in the original package.
• If your doctor tells you to stop taking your tablets, take any tablets you have left back to
your pharmacist. If your tablets become discoloured or deformed, take them back to
your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What CRESTOR contains:
The active ingredient in Crestor is rosuvastatin calcium. Crestor film-coated tablets contain
either 10 mg or 20 mg rosuvastatin in them.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, calcium
phosphate, crospovidone, magnesium stearate, hypromellose, glycerol triacetate, titanium
dioxide (E171) and red iron oxide (172).
What CRESTOR looks like and contents of the pack
Crestor 10 mg film-coated tablets are pink, round and marked with “ZD4522 and 10” on
one side and plain on the reverse.
Crestor 20 mg film-coated tablets are pink, round and marked with “ZD4522 and 20” on
one side and plain on the reverse.
Crestor Tablets comes blister pack containing 28, 30 or 90 tablets.
Product Licence Holder and Manufacturer
CRESTOR is manufactured by AstraZeneca Reims, France. It is procured from within the
EU by the Product Licence Holder: Swinghope Limited, Brandon House, Marlowe Way,
Croydon CR0 4XS and repackaged by Interport Limited, Brandon House, Marlowe Way,
Croydon CR0 4XS.
CRESTOR® 10 mg Tablets/
Rosuvastatin 10 mg Tablets

PL No: 10380/1045

POM

PL No: 10380/1046

CRESTOR® 20 mg Tablets/
Rosuvastatin 20 mg Tablets

Leaflet revision date: 04/03/2014
Crestor® is a registered trademark of the AstraZeneca group of companies.
H.E.A.R.T UK - The Cholesterol Charity - provides information and advice for patients
through a membership magazine, health and diet fact sheets and a helpline manned by
nurses and dieticians.
T04910

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